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The diaphragm and lubricant gel for prevention of HIV acquisition in Southern African women: results of a randomized controlled trial
Presented by Nancy Padian, United States.
Padian N.1, van der Straten A.1, Ramjee G.2, Chipato T.3, DeBruyn G.4, Blanchard K.5, Shiboski S.6, Montgomery E.1, Fancher H.1, Cheng H.1, Rosenblum M.7, van der Laan M.7, Jewell N.7, McIntyre J.4, the MIRA Study Team
1University of California, Women's Global Health Imperative, San Francisco, United States, 2Medical Research Council, Durban, South Africa, 3UZ-UCSF Research Programme on Women's Health, Harare, Zimbabwe, 4University of Witwatersrand, Perinatal HIV Research Unit, Johannesburg, South Africa, 5Ibis Reproductive Health, Cambridge, United States, 6University of California, Epidemiology & Biostatistics, San Francisco, United States, 7University of California, Biostatistics, Berkeley, United States
Objectives: Female-controlled HIV prevention methods are an urgent priority. We evaluated the effect of providing All-flex® latex diaphragm, Replens® lubricant gel and condoms (intervention) compared to condoms-alone (control) on HIV seroincidence in women.
Methods: We conducted an open-label, randomized controlled trial among 4948 HIV-negative, sexually-active women at three sites in South Africa and Zimbabwe. Women were followed quarterly for 12 to 24 months to assess HIV-status, product use, and adverse events. HIV-seroincidence was compared between study arms by intent-to-treat (ITT), per-protocol, and direct effects analyses, controlling for study sites.
Results: Baseline characteristics were balanced between arms: almost 80% of the sample was under 35 years of age, and reported an average of 2.2 lifetime sexual partners, 67% currently lived with their partner, 59% were married, 56% earned income, and 44% graduated from high school. Only 3 women had ever used a diaphragm, 87% had ever used condoms. Retention rate was over 92%, and we observed an overall HIV incidence of 4.0% per 100 woman-years. Arm-specific incidence and relative hazard by intent-to-treat and other types of analysis will be reported at the meeting. Over the course of the study, women in the intervention arm reported diaphragm use at last sex 73% of the time. Overall, condom use at last sex was reported 69% of the time. The proportions of participants reporting adverse events (60.4% vs. 60.7%) and serious adverse events (5.1% vs. 4%) were similar between arms.
Conclusion: The trial was successfully implemented, and study product uptake was high. The effects of providing the diaphragm and lubricant gel in addition to provision of a comprehensive HIV prevention package will be discussed at the meeting.
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